MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCFJ8L
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30210273m number, and no internal action related to the complaint was found during the review.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an ez steer¿ nav ds bi-directional electrophysiology catheter that was reported to have a broken tip after use.It was reported that at the end of the procedure when the physician pulled the catheter out the insulation was showing at the tip of the ez steer¿ nav ds bi-directional electrophysiology catheter and it appeared to be broken.The issue of broken tip with internal components exposed has been assessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an ez steer¿ nav ds bi-directional electrophysiology catheter that was reported to have a broken tip after use.It was reported that at the end of the procedure when the physician pulled the catheter out the insulation was showing at the tip of the ez steer¿ nav ds bi-directional electrophysiology catheter and it appeared to be broken.The issue of broken tip with internal components exposed has been assessed as an mdr reportable malfunction.On 10/8/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found no exposed wires that can be seen and the tip looks like a normal functioning catheter.On 10/16/2019, the complaint catheter was further inspected, and it was found with a slight bent on the tip.No internal parts exposed on anchor window.According to product analysis lab (pal), the integrity of the device is maintained.The catheter conditions were reviewed and determined the findings are not mdr reportable since the potential risk that these findings could cause or contribute to a serious injury or death are remote.Device evaluation details: the device evaluation has been completed.The first visual inspection performed and found no exposed wires that can be seen and the tip looks like a normal functioning catheter.A second visual inspection was performed and the catheter tip was found with a slightly bent on the tip.Then, a deflection test was performed and it was found within specifications, the catheter was deflecting correctly.The catheter pass the tip lumen tilt test.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the tip bent cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.Manufacturer¿s ref # (b)(4).

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8809578
• Report Number: 2029046-2019-03436
• Device Sequence Number: 326986
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: 10846835003048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2022
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 30210273M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1